Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems

NCT ID: NCT06559800

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-19
• Study Completion Date: 2024-11-30

Brief Summary

The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children/youth aged 10-16 years. YourSkills is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR).

The main questions the project aims to answer are:

• What are the preliminary effects of the child/youth CBT-VR-program?
• What is the level of child/youth engagement in the CBT-VR program?
• What are the experiences of parents, children/youth and therapists of the program?

The CBT-VR program is delivered at clinics during ten individual sessions. Parents will answer quantitative measurements before and after treatment, children will answer quantitative measurements before, during and after treatment. Within- group analyses will be conducted to examine experiences and preliminary effects of the program. Parents, children and clinicians are also asked to participate in a qualitative interview after the program has ended.

Detailed Description

Cognitive behavioral therapy (CBT) for children with behavior problems often include anger management training, social skills training, and problem-solving training. These have been shown to reduce anger and aggressive behaviors with small to moderate effects.

In a study in the Netherlands, the CBT-VR treatment program YourSkills was developed and evaluated for boys with aggressive behavior aged 8-13 years (Alsem et al, 2023). The treatment builds on CBT and includes brief role-plays conducted in virtual reality (VR). VR can provide a safe and gradual platform to practice.

PURPOSE AND RESEARCH QUESTIONS:

The aim of the pilot study is to evaluate preliminary effects and feasibility of the CBT-VR program YourSkills in Sweden for children/youth aged 10-16. The specific research questions are as follows:

1. What are the preliminary effects of the CBT-VR program on children's behavioral problems, well-being, parents' emotion regulation, parenting strategies, and family conflicts?

2. What is the level of child engagement in the CBT-VR program (e.g., the number of sessions, homework completion and dropout rates)?

3. What are the experiences of parents, children and therapists of the program (e.g., its effectiveness, acceptability, usefulness as well as relevance of the strategies taught)?

METHODS:

This project consists of a small pilot study of the CBT-based program YourSkills.

In the present project we target children/youth aged 10-16 years (n=10 families). The design is based on a mixed-methods approach. Evaluation of the intervention is conducted using within-group design (repeated measurements before, during, and after the intervention).

Families will be recruited through clinics and advertisements. They are directed to a webpage with information about the study and contact information to the researchers. Families provide informed consent to participate. Upon a participant expressing interest of the study, a member of the research team will contact the participant for a screening of inclusion and exclusion criteria.

The treatment is evaluated quantitatively by parents and children, using validated assessment scales before and after treatment, and by children with single questions before, during, and after the intervention. Additionally, qualitative interviews will be conducted with participants who consent to participate in an interview. Interviews will be recorded and transcribed. Clinicians at the clinics are invited to answer questions regarding their experiences of delivering the program.

In another separate pilot study we evaluate parent training with role-plays in virtual reality: "Pilot study of parent training with role-plays in virtual reality for parents of children with behavior problems".

POWER CALCULATION:

The quantitative and qualitative data that will be collected for ten families is considered sufficient to provide understanding and preliminary insight into acceptability, usability, relevance, and effectiveness.

ANALYSES:

The plan is to compare changes during the intervention using paired t-tests, descriptive statistics, description of reliable and clinical change, and calculation of effect sizes. If appropriate, non-parametric alternatives will be employed. The qualitative analyses will be conducted using content analysis or thematic analysis.

Conditions

Child Behavior Problem; Disruptive Behavior; Oppositional Defiant Disorder; Conduct Problems; Aggression; Anger

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavior therapy for children and youth with role-plays in virtual reality

Child/youth cognitive-behavioral program with up to 10 individual, face-to-face, weekly sessions

Group Type: EXPERIMENTAL

YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality

Intervention Type: BEHAVIORAL

A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills.

Interventions

YourSkills: Cognitive behavioral therapy for children/youth with role-plays in virtual reality

A program for children/youth with anger problems or aggressive behaviors based on social learning theory and cognitive behavior therapy (CBT), incorporating virtual reality (VR) when conducting brief role-plays. The program includes similar strategies as other CBT-oriented programs for anger problems, with the addition of VR for practicing skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child/youth aged between 10-16 years with increased levels of anger or disruptive behaviors,
• The child's behavior problems is elevated on questions targeting behavioral problems (SDQ conduct problems subscale).

Exclusion Criteria

• Child/youth is below 10 years or above 16 years of age
• No increased levels of anger or disruptive behaviors
• Child/youth is diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors
• Child/youth has epilepsy or migraine

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PRIMA

UNKNOWN

Sponsor Role: collaborator

Psykologpartners

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Pia Enebrink

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pia Enebrink, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Central Contacts

Pia Enebrink, PhD

Role: CONTACT

pia.enebrink@ki.se

+46852487738

References

Alsem SC, van Dijk A, Verhulp EE, Dekkers TJ, De Castro BO. Treating children's aggressive behavior problems using cognitive behavior therapy with virtual reality: A multicenter randomized controlled trial. Child Dev. 2023 Nov-Dec;94(6):e344-e361. doi: 10.1111/cdev.13966. Epub 2023 Jul 17.

Reference Type: BACKGROUND

PMID: 37459452 (View on PubMed)

Other Identifiers

2024-00813-01 - Children

Identifier Type: -

Identifier Source: org_study_id